The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Legal and Regulatory Challenges for Emerging Regenerative Medicine Solutions for Diabetes
Open accessAbstract
Regenerative medicine solutions for type 1 diabetes are a rapidly developing field of medical technology. To date, these solutions have been principally cell-based treatments and at present, in Europe, these therapies are regulated under European Union regulations for advanced therapy medicinal products. But now, new emerging technology combining cellular therapy with medical devices is under development. The potential of this novel hybrid model to create a bioartificial pancreas to treat type 1 diabetes is tantalizing. However, incorporating medical devices creates a further layer of regulatory complexity. This article seeks to expose the complexity of this legal and regulatory landscape and demonstrate how evolving technology could challenge the entire existing legal paradigm. We start by summarizing the status of the only established cell-based therapy—transplantation. We set out the regulation of cellular therapies, their classification, and the role of statutory bodies. We examine the bottleneck of therapies moving from bench to bedside, and we consider the additional challenges of products, which use a combination of cells and medical devices. Finally, we argue that for the potential of this rapidly growing area of technology to be realized a seismic shift in how we regulate frontier cellular therapies will be required.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Non-genetically modified cell therapies and their derived extracellular vesicles are particularly promising because of lower regulatory complexity and potential for earlier clinical adoption.
“Among these, non-genetically modified cell therapies and their derived extracellular vesicles (EVs) are particularly promising because of their lower regulatory complexity and potential for earlier clinical adoption (Wang et al., 2021; Bahmani and Ullah, 2022; Thom and Cronin, 2024).”
From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Thom and Cronin, 2024
In “Regulating Novel Cellular Therapies” (page unavailable), the paper says genetically modified cells face additional directives, supporting a narrower point about regulatory burden. “The ATMP Bottleneck” discusses barriers to bringing cell therapies to market, but the paper does not establish that non-genetically modified therapies will be adopted earlier or address their derived extracellular vesicles. (LLM, conf=0.82)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Hering, B. J., Ballou, C. M., Bellin, M. D., Payne, E. H., Kandeel, F., Witkowski, P., Alejandro, R., Rickels, M. R., & Barton, F. B. (2023) · Diabetologia · doi:10.1007/s00125-022-05804-4 · Cited by 51
Flagged first, then by citations
Research works printed but not linked: 28
- Pathak, 2019, Therapies for type 1 diabetes: current scenario and future perspectives., Clin Med Insights Endocrinol Diabetes, 12, 117955141984452, 10.1177/1179551419844521 · DOI
- McCrimmon, 2018, SGLT inhibitor adjunct therapy in type 1 diabetes., Diabetologia, 61, 2126, 10.1007/s00125-018-4671-6 · DOI
- Gruessner, 2022, International pancreas transplant registry report—a review., Transplant Proc, 2022, 1918, 10.1016/j.transproceed.2022.03.059 · DOI
- Berney, 2022, International islet transplant centers: a worldwide survey of activities and practices in clinical islet of langerhans transplantation., Transpl Int, 35, 10507, 10.3389/ti.2022.10507 · DOI
- Wojtusciszyn, 2019, Indications for islet or pancreatic transplantation: statement of the TREPID working group on behalf of the Société francophone du diabète (SFD), Société francaise d’endocrinologie (SFE), Société francophone de transplantation (SFT) and Société française de néphrologie—dialyse—transplantation (SFNDT)., Diabetes Metab, 45, 224, 10.1016/j.diabet.2018.07.006 · DOI
- Dholakia, 2017, The rise and potential fall of pancreas transplantation., Br Med Bull, 124, 171
- Gruessner, 2016, Pancreas transplantation of US and non-US cases from 2005 to 2014 as reported to the United Network for Organ Sharing (UNOS) and the International Pancreas Transplant Registry (IPTR)., Rev Diabet Stud, 13, 35, 10.1900/RDS.2016.13.35 · DOI
- Cimen, 2019, Challenges of pancreas transplantation in developing countries, exploring the Turkey example., World J Transplant, 9, 158, 10.5500/wjt.v9.i8.158 · DOI
- Manrique, 2009, Relaparotomy after pancreas transplantation: causes and outcomes., Transplant Proc, 41, 2472, 10.1016/j.transproceed.2009.06.165 · DOI
- Caiazzo, 2015, Impact of procedure-related complications on long-term islet transplantation outcome., Transplantation, 99, 979, 10.1097/TP.0000000000000458 · DOI
- Berney, 2022, From islet of langerhans transplantation to the bioartificial pancreas., Presse Med, 51, 104139, 10.1016/j.lpm.2022.104139 · DOI
- Bellin, 2020, Transplant strategies for type 1 diabetes: whole pancreas, islet and porcine beta cell therapies., Diabetologia, 63, 2049, 10.1007/s00125-020-05184-7 · DOI
- Cornwall, 2021, Advanced therapies: innovation, regulation and patentability in the UK., Biosci Law Rev, 18, 11
- Green, 2021, Type 1 diabetes in 2017: global estimates of incident and prevalent cases in children and adults., Diabetologia, 64, 2741, 10.1007/s00125-021-05571-8 · DOI
- Photiadis, 2021, The current status of bioartificial pancreas devices., ASAIO, 67, 370, 10.1097/MAT.0000000000001252 · DOI
- Wassmer, 2022, Bio-engineering of pre-vascularized islet organoids for the treatment of type 1 diabetes., Transpl Int, 35, 10214, 10.3389/ti.2021.10214 · DOI
- Hanna, 2022, Advances and challenges of endocrine pancreas bioengineering., Curr Opin Endocr Metab Res, 23, 100320, 10.1016/j.coemr.2022.100320 · DOI
- Wassmer, 2020, Generation of insulin-secreting organoids: a step toward engineering and transplanting the bioartificial pancreas., Transpl Int, 33, 1577, 10.1111/tri.13721 · DOI
- Iglesias-Lopez, 2021, Current landscape of clinical development and approval of advanced therapies., Mol Ther Methods Clin Dev, 23, 606, 10.1016/j.omtm.2021.11.003 · DOI
- Ronco, 2021, Price and reimbursement of advanced therapeutic medicinal products in Europe: are assessment and appraisal diverging from expert recommendations?, J Pharm Policy Pract, 14, 30, 10.1186/s40545-021-00311-0 · DOI
- Ten Ham, 2018, Challenges in advanced therapy medicinal product development: a survey among companies in Europe., Mol Ther Methods Clin Dev, 11, 121, 10.1016/j.omtm.2018.10.003 · DOI
- Jarman, 2021, Neither protective nor harmonized: the crossborder regulation of medical devices in the EU., Health Econ Policy Law, 16, 51, 10.1017/S1744133120000158 · DOI
- Groth, 1994, Transplantation of porcine fetal pancreas to diabetic patients., Lancet, 345, 735, 10.1016/S0140-6736(95)90910-9 · DOI
- Porrett, 2022, First clinical-grade porcine kidney xenotransplant using a human decedent model., Am J Transplant, 22, 1037, 10.1111/ajt.16930 · DOI · Paper page
- Reardon, 2022, First pig-to-human heart transplant: what can scientists learn?, Nature, 601, 305, 10.1038/d41586-022-00111-9 · DOI
- Witkowski, 2021, The demise of islet allotransplantation in the United States: a call for an urgent regulatory update., Am J Transplant, 21, 1365, 10.1111/ajt.16397 · DOI
- Piemonti, 2021, US Food and Drug Administration (FDA) panel endorses islet cell treatment for type 1 diabetes: a pyrrhic victory?, Transpl Int, 34, 1182, 10.1111/tri.13930 · DOI
- Auzanneau, 2021, Heterogeneity of access to diabetes technology depending on area deprivation and demographics between 2016 and 2019 in Germany., J Diabetes Sci Technol, 15, 1059, 10.1177/19322968211028608 · DOI
Cited by
Sorted by citations
Chiu, Y.-S., Wang, K.-L., & Wu, K.-L. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1644318 · Cited by 17
Metadata
- Authors
- Thom, R. L., Cronin, A. J., & the VANGUARD Consortium
- Affiliations
- Guy's Hospital (GB)
- Corresponding author
- Thom, Rebecca L.
- Venue
- Transplantation
- Published
- 2023-09-26
- Volume
- 108
- Issue
- 5
- Pages
- 1072-1079
- ISSN
- 0041-1337 (ISSN-L)
- PMC
- PMC11042516
- OpenAlex
- W4387034089
- Cited by
- 12
- References
- 1
- Citations by year
- 2026: 3 · 2025: 8 · 2024: 1
- FWCI
- 2.13
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Transplantation (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion, cc-by)
- Funders
- European Commission (HORIZON2020, 874700)
- Topics
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
- Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
- Keywords
- type 1 diabetes, regenerative medicine, cell therapy, advanced therapy medicinal products, bioartificial pancreas, clinical translation, European Union regulation
- MeSH terms
- Diabetes Mellitus, Type 1, European Union, Humans, Government Regulation, Regenerative Medicine, Cell- and Tissue-Based Therapy
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
